CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Long Nail, Right Gamma4 10x320mm recalled by Stryker
Stryker is recalling Long Nail, Right Gamma4 10x320mm x 125, component of the Gamma4 System, distributed nationwide in the US. The recall was initiated on 28 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1914-2025
- FDA event ID
- 96927
- Recalling firm
- Stryker, Selzach
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2025
- FDA classified
- 6 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 May 2025 | Recall initiated by company | |
| 6 Jun 2025 | Classified by FDA | +9 days |
| 18 Jun 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Product as listed by the FDA
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Where it was distributed
Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
Questions about this recall
Why was it recalled?
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Which lots are affected?
Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Where was it sold?
Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stryker
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pkg., Strykeflow Suction/irrigator Ps recalled by Stryker | Stryker | Packaging Defects | Nationwide |
| Device | CLASS II | Ahto Tube Set With Tip Packaging recalled by Stryker | Stryker | Packaging Defects | Nationwide |
| Device | CLASS II | Pkg., Single Spike Tube Set recalled by Stryker | Stryker | Packaging Defects | Nationwide |
| Device | CLASS II | Ahto Tube Set Packaging recalled by Stryker | Stryker | Packaging Defects | Nationwide |
| Device | CLASS II | Ahto Dual Spike Tube Set Packaging recalled by Stryker | Stryker | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |